Alexza Pharmaceuticals (ALXA) Reports Large Q3 Loss

November 9, 2009 4:17 PM EST

Alexza Pharmaceuticals Inc. (NASDAQ: ALXA) reports a Q3 loss of $1.95 vs. the analyst estimate of ($0.29). No revenues reported for the quarter.

Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. During the third quarter, Alexza completed the enrollment and data analysis of the two remaining AZ-004 non-pivotal safety and NDA-supporting studies. These studies were a pulmonary safety study in subjects with chronic obstructive pulmonary disease, or COPD and a pulmonary safety study in subjects with asthma.

Alexza completed a Phase 1 placebo-controlled study in 53 subjects with predominantly moderate-to-severe COPD and a Phase 1 placebo-controlled study in 52 subjects with mild-to-moderate persistent asthma, to assess the pulmonary safety of AZ-004 in these populations. The studies employed double-blind, parallel-group designs. In each study, subjects were given two doses of Staccato placebo or 10 mg AZ-004, ten hours apart. Spirometry testing and other safety assessments were performed at several time points up to 24 hours after the second dose. The primary safety measure was FEV1 (forced expiratory volume in one second), a standard test of lung function. Decreases in FEV1 versus baseline, respiratory symptoms, and use of a quick-relief bronchodilator occurred in both treatment groups, but were more frequent in each study after treatment with AZ-004. There were no serious or severe respiratory adverse events. All respiratory symptoms developing after treatment were either self-limiting or readily managed with the inhaled bronchodilator.

Alexza has now completed the five planned non-pivotal safety and NDA-supporting studies for the AZ-004 NDA. The Company believes that these data, along with data from the other efficacy and safety trials conducted with AZ-004, adequately demonstrate the efficacy and safety of AZ-004 for the proposed indication.

In July 2009, Alexza completed its AZ-004 pre-NDA meeting with the FDA and the Company continues to project its AZ-004 NDA submission for early 2010.

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